Multi-polar connector

ABSTRACT

A connector for connecting to an energy source such as a pulse generator for a cardiac stimulator system. The connector assembly includes a pin, at least one ring and a sleeve composed of an insulative hard polymer molded between the pin and ring such that the sleeve provides electrical insulation between the pin and ring and mechanically couples the pin and ring.

TECHNICAL FIELD

This application relates to a connector for connecting a lead to anenergy source such as a cardiac stimulator.

BACKGROUND

Connector assemblies are used to couple a conductor with a device. Forinstance, a connector is used to couple a cardiac stimulator system suchas a pacemaker, an anti-tachycardia device, a cardioverter or adefibrillator with a lead having an electrode for making contact with aportion of the heart.

When leads with multiple conductors are involved, the conductors areindividually, mechanically and electrically coupled with the pulsegenerator at a proximal end of the multiple conductors. The multipleconductors at the proximal end are electrically insulated from eachother to prevent shorts and limit electrical leakage between conductors.Medical adhesive is used to bond and insulate the multiple conductors atthe proximal end of the lead. However, the process of using medicaladhesive is timely and costly. In addition, the medical adhesive bondsinconsistently, sometimes resulting in mechanical and electricalseparation between the components, and resulting in dimensionalinconsistency.

The proximal end of the lead includes a terminal connection whichprovides the electrical and mechanical connection between the pacemakerand the proximal end of the lead. When inserted into the pacemaker, thecomponents of the terminal connection undergoes axial stress as theimplanter forces the proximal end of the lead into the pacemaker. Afterinserted, the implanter may pull on the lead to ensure the terminal endis sufficiently seated in the pacemaker, placing additional axial stresson the terminal connection.

In addition, connector assemblies are subjected to a variety of testsincluding axial loading to test the strength of the coupling of thecomponents. Existing connector assemblies often include numerouscomponents and require numerous steps in the assembly process to providethe desired connection between the components. Connector designs includecomponents that are welded together, bonded with adhesive or acombination of both. Welded components require subassembly prior toassembly with other components and may require additional componentssuitable for making weld connections. Bonding components with adhesivealso requires subassembly. Additionally, bonding components withadhesive requires time to cure and is a messy process. Connector designsincluding components that are welded together or bonded with adhesive ora combination of both add additional elements and steps to themanufacturing and assembly process. These additional elements increasethe complexity of the component and can represent a bottle-neck in themanufacturing and assembly process of the connector assembly.

SUMMARY

A connector assembly includes a pin extending from a pin distal end to apin proximal end. The pin further includes an intermediate portionbetween the distal end and the proximal end. In addition, the connectorassembly includes at least one ring extending from a ring distal end toa ring proximal end and having a ring intermediate portion therebetween.A molded insulative polymer is between the pin and the ring, the polymermechanically couples the pin and the ring, and the insulative polymerinsulates the pin from the ring.

Several options for the connector assembly are as follows. For instance,in one option, the pin has a first outer diameter and the ring has asecond outer diameter, and the first diameter is substantially the sameas the second diameter. In another option, the connector assemblyfurther includes a second ring, and the insulative polymer is betweenthe pin, the first ring and the second ring, and the second ring ismechanically coupled to the pin by the polymer. In another example, thering further includes at least one passage, and the molded polymer ismolded within the at least one passage. The pin includes, in anotheroption, at least one chamfer, and the molded insulative polymer ismolded within the chamfer.

Other options are follows. For instance, the pin optionally has at leastone chamfer formed thereon. In another option, the ring includes a fullboss and a full chamfer, and/or the ring includes an extension thereon,the extension having a partial boss and a partial chamfer thereon. Inyet another option, an interior surface of the ring includes groovesformed thereon, or the grooves are oblique to a longitudinal axis of thering. The pin further optionally includes a boss formed thereon, and/orthe pin boss further includes grooves formed thereon, and/or the pinfurther includes grooves formed on a distal portion of the pin.

In another embodiment, an assembly comprises a connector assembly. Theconnector assembly includes a pin extending from a pin distal end to apin proximal end, and having a pin intermediate portion therebetween.The connector assembly further includes at least one ring extending froma ring distal end to a ring proximal end and having a ring intermediateportion therebetween, and a molded insulative polymer between the pinand the ring, the polymer mechanically couples the pin and the ring, andthe insulative polymer insulates the pin from the ring. The assemblyfurther includes a lead having a lead body, the lead coupled with theconnector assembly.

Several options for the assembly are as follows. For instance, theconnector assembly has a first outer diameter, the lead having a secondouter diameter, and the first outer diameter and the second outerdiameter are substantially the same. In another option, the connectorassembly further includes a groove on an outer diameter of the connectorassembly, the groove configured to receive a portion of a pulsegenerator, and/or the connector assembly further includes a secondgroove on the outer diameter. In another option, a second ring, and athird ring, and the insulative polymer is between the pin, the firstring, the second ring, and the third ring, the second ring and the thirdring mechanically coupled to the pin by the polymer. In yet anotheroption, the pin further includes a pin boss formed thereon, and the pinboss further includes grooves formed thereon.

In one embodiment, a method comprises forming a pin, forming at leastone ring, molding a sleeve between the pin and the ring, includingmechanically coupling the pin with the ring. Several options for themethod are as follows. For instance, the method further comprisescoupling a lead with the pin, the at least one ring, and the sleeve toform an assembly having an isodiametric outer diameter. In anotheroption, the method further includes forming a second ring, and moldingthe sleeve between the ring, the pin, and the second ring. In yetanother option, the method further includes swaging a conductor within apassage of the at least one ring, and/or welding a conductor within apassage of the at least one ring. A further option for the methodincludes forming an extension on the ring, and/or forming a partial bossand a partial chamfer on the extension.

The construction of the connector does not require weld joints oradhesive bonds between components. The result is a connector with fewercomponents, fewer steps in the assembly process, reduced size andsmaller diameter, improved insulative properties and improved mechanicalstrength. The connector is useful for unipolar, multipolar, uniradial,and co-radial construction.

These and other embodiments, aspects, advantages, and features of thepresent invention will be set forth in part in the description whichfollows, and in part will become apparent to those skilled in the art byreference to the following description of the invention and referenceddrawings or by practice of the invention. The aspects, advantages, andfeatures of the invention are realized and attained by means of theinstrumentalities, procedures, and combinations particularly pointed outin the appended claims and their equivalents.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 is a perspective view illustrating a connector assembly asconstructed in accordance with one embodiment;

FIG. 2 is a cross-sectional view illustrating a connector assembly asconstructed in accordance with one embodiment;

FIG. 3 is a side elevational view illustrating a pin as constructed inaccordance with one embodiment;

FIG. 4A is a side elevational view illustrating a ring as constructed inaccordance with one embodiment;

FIG. 4B is a cross-sectional view illustrating a ring as constructed inaccordance with one embodiment;

FIG. 4C is a perspective view illustrating a ring as constructed inaccordance with one embodiment;

FIG. 4D is an end view illustrating a ring as constructed in accordancewith one embodiment;

FIG. 5 is a cross sectional view illustrating a portion of a connectorassembly as constructed in accordance with one embodiment;

FIG. 6 is a cross-sectional view of a portion of a ring as constructedin accordance with one embodiment;

FIG. 7 is a cross-sectional view of a portion of a ring as constructedin accordance with one embodiment;

FIG. 8 is a cross-section view of a connector assembly as constructed inaccordance with another embodiment;

FIG. 9A is a cross-sectional view taken along 9A—9A of FIG. 9D of a ringas constructed in accordance with one embodiment;

FIG. 9B is a cross-sectional view taken along 9B—9B of FIG. 9D of a ringas constructed in accordance with one embodiment;

FIG. 9C is a perspective view of a ring as constructed in accordancewith one embodiment;

FIG. 9D is an end view of a ring as constructed in accordance with oneembodiment;

FIG. 10A is a perspective view of a connector assembly as constructed inaccordance with another embodiment;

FIG. 10B is a cross-sectional view of a connector assembly asconstructed in accordance with one embodiment;

FIG. 10C is a perspective view of a portion of a connector assembly asconstructed in accordance with another embodiment;

FIG. 10D is a perspective view of a portion of a connector assembly asconstructed in accordance with another embodiment;

FIG. 11A is a side elevational view of a pin of a connector assembly asconstructed in accordance with one embodiment;

FIG. 11B is a cross-sectional view taken along 11B—11B of FIG. 11A;

FIG. 11C is a cross-section view of a pin of a connector assembly asconstructed in accordance with one embodiment;

FIG. 12 is a side elevational view of a portion of a pin of a connectorassembly as constructed in accordance with another embodiment;

FIG. 13 is a cross-sectional view of a connector assembly as constructedin accordance with one embodiment;

FIG. 14 is a cross-sectional view of a connector assembly as constructedin accordance with one embodiment;

FIG. 15 is a perspective view of a connector assembly as constructed inaccordance with another embodiment;

FIG. 16A is a side elevational view of a ring as constructed inaccordance with one embodiment;

FIG. 16B is a cross-sectional view taken along 16B—16B of FIG. 16D of aring as constructed in accordance with one embodiment;

FIG. 16C is a perspective view of a ring as constructed in accordancewith one embodiment;

FIG. 16D is an end view of a ring as constructed in accordance with oneembodiment;

FIG. 17 is a perspective view of a ring as constructed in accordancewith one embodiment;

FIG. 18 is a cross-sectional view of a connector assembly as constructedin accordance with another embodiment.

DETAILED DESCRIPTION OF EMBODIMENTS

In the following detailed description, reference is made to theaccompanying drawings which form a part hereof, and in which is shown byway of illustration specific embodiments in which the invention may bepracticed. These embodiments are described in sufficient detail toenable those skilled in the art to practice the invention, and it is tobe understood that other embodiments may be utilized and that structuralchanges may be made without departing from the scope of the presentinvention. Therefore, the following detailed description is not to betaken in a limiting sense, and the scope of the present invention isdefined by the appended claims and their equivalents.

FIGS. 1 and 2 illustrate a connector assembly 100 which connects aconductor to a device or an energy source. The connector assembly 100includes a pin 105, at least one ring 110 and a unitary sleeve 115formed from a molded insulative hard polymer. In one option, the pin 105includes a lumen 104 therethrough, which is sized and configured toreceive a stylet or guidewire therethrough. Alternatively, the lumen 104is configured to receive other types of devices therethrough. In yetanother option, the pin 105 is solid, for example the lumen 104 isfilled with the hard polymer.

Various materials are suitable for the insulative hard polymer. Forexample, suitable materials include, but are not limited to, PEEK (TM),polyurethane, tecothane, acrylic, polycarbonate, polysulfone, highdurometer silicone, materials having a durometer of about 80 Shore a, ormaterials having a dielectric constant of 300-500V/0.001 inches.

The insulator polymer separates the pin 105 and the ring 110. Theinsulative hard polymer of the sleeve 115 provides improved electricalisolation between the pin 105 and ring 110 and also provides improvedmechanical coupling between the pin 105 and ring 110. Although theconnector assembly 100 shown in FIG. 1 illustrates a bipolar connector,the molded sleeve 115 is suitable for use with a unipolar or multipolardesign.

The sleeve 115 is received within a portion of an energy source suchthat the interface between the connector assembly 100 and portion of theenergy source prevents body fluid from entering the energy source. Inone embodiment, the sleeve 115 includes a groove 106 for mating with aportion, such as a projection, of the pulse generator 80 (FIG. 5). Inanother option, the sleeve 115 includes a ridge for mating with aportion of the pulse generator 80 (FIG. 5). The groove 106 allows forthe physician to receive a tactile indication of when a connectorassembly 100 has been properly inserted into the pulse generator 80(FIG. 5).

FIG. 2 shows one embodiment, the distance 165 between a portion of thepin 105 and a portion of the ring 110 is in the range of about 0.005inches which is achieved by use of the molded polymer for the sleeve115. One benefit of forming the sleeve 115 from the insulative hardpolymer is that it allows the pin 105 and ring 110 to be assembled incloser proximity while providing the required insulative propertiesbetween the pin 105 and ring 110. Thus, for a given electricalperformance, the molded sleeve 115 provides for a connector assembly 100having smaller dimensions.

FIG. 2 illustrates one example of how the dimensional consistency andmechanical lock is maintained in the longitudinal direction at least inpart by a portion of the insulative hard polymer that is molded into atleast one chamfer portion 130 of the pin 105. In another option, aproximal portion 135 of the insulative hard polymer is molded proximalto the ring 110, between the pin 105 and ring 110. In a further option,a distal portion 140 of the insulative hard polymer is molded distal tothe ring 110.

FIG. 3 illustrates one embodiment of the pin 105 in greater detail,where the pin 105 extends from a proximal end 120 to a distal end 125.The pin 105 includes a chamfer 130 in between the proximal end 120 andthe distal end 125. The chamfer 130 receives a portion of the sleeve 115(FIG. 2) therein, for example, the sleeve 115 (FIG. 2) is molded intothe chamfer 130. In another option, the pin 105 includes a boss 132which is received by the sleeve 115 (FIG. 2). The chamfer 130 and theboss 132, in combination of the sleeve 115 (FIG. 2), assist inpreventing axial movement of the sleeve 115 (FIG. 2) relative to the pin105.

FIGS. 4A-4D, 6 and 7 illustrate a ring 110 in greater detail. The ring110 extends from a proximal end 112 to a distal end 114. Disposed at thedistal end 114, in one option, is an extension 122. In one option, theextension 122 includes one or more passages 155, which are configured toreceive a conductive element therethrough. The passages 155, also shownin FIG. 6, receive the conductive element therethrough. In oneembodiment, the conductive elements 195 are secured inside the passages155 by swaging the ring 110. FIG. 7 illustrates another option in whichthe ring 110 includes longitudinal grooves 205 on an outer surface 210of the ring 110. The grooves 205 receive a pair of conductive elements195 therein. In one option, the conductive elements 195 are weldedwithin the grooves 205. In another option, the conductive elements 195are crimped within the longitudinal grooves 205.

FIG. 5 illustrates the connector assembly 100 coupled with a lead 90 anddisposed within a pulse generator 80. It should be noted that theconnector assembly 100 includes, but is not limited to, any of the aboveor below discussed connector assemblies. The lead 90 includes a leadbody 92 having an inner conductor 196, an inner insulative sleeve 197,and an outer coiled conductor 198. The inner coiled conductor 196, inone option, is comprised of two inner conductor elements, eachindividually insulated and coupled to the pin 105. The outer coiledconductor 198, in one option, is comprised of two inner conductorelements, each individually insulated and coupled to the pin 105.

As mentioned above, the connector assembly 100 is connected to a lead 90having a first conductive element electrically insulated from a secondconductive element. In one embodiment, the first conductive elementextends over a portion of the pin 105 and is electrically coupled to thepin 105. In another embodiment, the second conductive element extendsover a portion of the ring 110 and electrically coupled to the ring 110.The first conductive element, in one option, is nested within a secondconductive element, the first and second conductive elements beingcoiled in a co-axial manner. In another option, the first conductiveelement and the second conductive element are wound co-radially. Thefirst conductive element is mechanically and electrically coupled to thepin 105 and the second conductive element is mechanically andelectrically coupled to the ring 110. Suitable methods for mechanicallyand electrically coupling include, but are not limited to, swaging,crimping, and welding.

The sleeve 115 includes an interface portion 190 which receives an innerinsulative sleeve 197. The interface portion 190 further abuts the innercoiled conductor 196. The inner insulative sleeve 197 surrounds theinner coiled conductor 196, and isolates the inner coiled conductor 196from the outer coiled conductor 198. An outer insulative sleeve 185surrounds the outer coiled conductor 198. The lead body 92 is mountedover the outer insulative sleeve 185.

The connector assembly 100 includes a sealing area 102, which abuts upagainst a first seal 82 of the pulse generator 80. The first seal 82comprises a pin seal zone and assists in preventing bodily fluids fromentering an implanted pulse generator 80. The connector assembly 100 isfurther coupled with a lead 90, as discussed above. The pulse generator80 further includes a second seal 84, which seals to the lead 90. Thesecond seal 84 seals in a ring seal zone.

FIG. 8 illustrates another embodiment of a connector assembly 100. Theconnector assembly includes the pin 105 and the ring 110, as discussedabove. The pin 105, in one option, has a distal chamfer 108. The distalchamfer 108 provides a location for making the electrical connectionwith the conductive element 195, including, but not limited to, byswaging, welding, and/or conductive epoxy.

FIGS. 9A, 9C, 9D illustrate various views of another embodiment of aring 110. The ring 110 includes a full chamfer 230, a full boss 235, apartial chamfer 240 and a partial boss 245. The full chamfer 230includes a recess which runs the full and/or substantially the fullcircumference of the ring 110. The full boss 235 includes a projectionwhich runs the full and/or substantially the full circumference of thering 110. The partial chamfer 240 and the partial boss 245 make up anextension portion 246 of the ring 110 that runs around at least aportion of the circumference. The extension portion of the unitary ring110 includes surfaces 160, 161 seen in FIG. 9A. Conductive elementscross over the surfaces 160, 161 and contact the unitary ring 110 in thepartial chamfer 240 portion of the ring 110.

FIG. 9B illustrates an embodiment of a ring 110 having grooves 255 onthe inner surface 109 of the ring 110 for receiving a portion of themolded unitary sleeve 115. In one embodiment, the grooves 155 areseparate angled grooves 155, where the angle is oblique to alongitudinal axis of the ring 110. The grooves may take a different formand other embodiments include but are not limited to, grooves 155running circumferentially and/or grooves that are continuous and run ina thread-like configuration.

Referring to FIG. 10A, the ring 110 having a full chamfer 230, a fullboss 235, a partial chamfer 240 and a partial boss 245, as discussedabove, are shown incorporated into a connector assembly 100′. The sleeve115 further includes, optionally, a partial sleeve boss 206 for allowingpassage of a conductor element. FIG. 10B illustrates the ring 110 inwhich a full boss 235 and a partial boss 245 are adapted for receiving alead body 92 thereover. The full boss 235 and the partial boss 245 havea reduced outer diameter 265 relative to the outer diameter 270 of theouter surface 210 of the ring 110. The lead body 92 further fits overthe partial chamfer 240 and the full chamfer 230 and abuts a distal edge290 of the ring 110. An area defined by a lead inner surface 285 and thefull chamfer 230 defines a bond zone 275 for use in bonding the leadbody 92 to the connector assembly 100′. In one option, the full chamfer230 is adapted for receiving a coupling ring 280 thereon.

FIGS. 10C and 10D illustrate another embodiment for the ring 110 and thesleeve 115 of the connector assembly 100′. The ring 110 has a full boss235, a partial chamfer 240 and a partial boss 245. The sleeve 115further includes, optionally, a partial sleeve boss 206′ and a partialsleeve chamfer 207 for allowing passage of a conductor element 195. Thechamfer 207 in one option comprises a spiral channel which isolates theconductor element 195. In a further option, the chamfer 207 is widerthan the conductor element 195, allowing for the chamfer 207 to bebackfilled, for example, by epoxy or welding material. It should benoted that the conductor element 195 is disposed within the chamfer 195after the welding of the sleeve 115. However, in another option, theconductor element 195 is disposed within the chamfer 195 before thewelding of the sleeve.

Referring to FIGS. 10A, 10B, 10C, and/or 10D, the coupling ring 280provides a bonding surface for coupling the lead body 92 to theconnector assembly 100′. The coupling ring 210 is confined within thefull chamfer 230 and is of a material suitable for bonding to the leadbody 92. The coupling ring 280 sits within the full chamfer 230 of thering 110, and the ring 110 provides structural rigidity that helps toconfine the coupling ring 210. The coupling ring 280 optionallycomprises a molded piece that is molded onto the ring 110. In oneembodiment, the coupling ring 280 is molded through openings in theunitary ring 110 that extend to the full chamfer 230. The coupling ring280 assists in securing the ring 110 relative to the sleeve 115 and pin105. Other embodiments include but are not limited to a coupling bandthat opens and snaps into place or expands to fit over the ring 110 andcontracts to fit within the full chamfer 230. In one option, thecoupling ring 280 is comprised of the same material as the lead body 92,for instance a polymer.

In FIG. 10B, the area defined by the lead inner surface 285 and thepartial chamfer 240 defines a conductor coupling zone 260. a conductorelement is positioned inside the partial chamfer 240 where it is coupledto the unitary ring 110. In one option, the conductor is welded insidethe partial chamfer 240. Suitable welding techniques include, but arenot limited to, laser welding, resistance welding or butt welding. Otherembodiments for coupling the conductor element inside the partialchamfer 240 include but are not limited to using a conductive adhesiveto couple the conductive element or positioning an annular member overthe conductor element and swaging the annular member.

The lead body 92 has a lead body outer diameter 295 which coincides withthe ring outer diameter 270 forming a continuous uninterrupted profile,and an isodiametric outer profile for the lead body 92 and the ring 110.This also provides a continuous and isodiametric profile for theconnector assembly 100′ and lead body 92 well suited for implantationapplications.

The sleeve 115 optionally includes a first sleeve chamfer 215 and asecond sleeve chamfer 220 for mating with a corresponding portion of animplantable device. In one embodiment, the unitary sleeve 115 includes akeyway groove which requires a quarter turn to complete engagement withan implantable device such as a pulse generator header.

FIG. 11A illustrates a pin 105′ having a boss 300 including pin bossgrooves 305. As illustrated in FIG. 11B, the pin boss grooves 305 createcavities for receiving the unitary sleeve 115 therein. The pin bossgrooves 305 help to prevent rotation of the unitary sleeve 115 about thepin 105′. The pin boss grooves 305, in one option, are longitudinalgrooves. Other embodiments include, but are not limited, to angledgrooves, threaded portions, or grooves having an arcuate shape, such asshown in FIG. 12. FIG. 11C illustrates yet another option for the boss300 which includes one or more flats 306, and optionally includes thegrooves of FIG. 11A, 11B, or 12. The one or more flats 306 assists inproviding rotational stability, and provides a less complexmanufacturing process than the grooves.

Referring again to FIG. 11A, the pin 105′, in another option, has pinridges 310. The pin ridges 310 include, in one option, one or morelongitudinal pin ridges 320 located on the pin 105′, for example at adistal portion 322. The longitudinal pin ridges 320 extend outward fromthe distal portion 322 and create cavities for receiving the sleeve 115.The pin ridges 310 include, in another option, angled pin ridges 315 inaddition to or in alternative to the longitudinal pin ridges 320. Theangled pin ridges 315, in one option, are formed at an angle which isoblique to the longitudinal axis of the pin 105′. The angled pin ridges315 extend outward from the distal portion 322 and create cavities forreceiving the unitary sleeve 115. Other embodiments for the angled pinridges 315 include, but are not limited to, thread like ridges. The pinridges 310 assist in preventing rotation of the unitary sleeve 115 aboutthe pin 105′. Other embodiments include but are not limited tolongitudinal or angled grooves in the distal portion 322 of the pin 105′to help prevent rotation of the unitary sleeve 115 about the pin 105′.

FIG. 13 illustrates an embodiment of a connector assembly 100″ includinganti-rotation features, for example, pin ridges 310 and/or ring interiorgrooves 255. These features assist in preventing rotation of the pin105, ring 110 and unitary sleeve 115 relative to one another.

The connector assembly 100″ includes a distal sleeve 330 surrounding thedistal portion 322 of the pin 105. The distal sleeve 330 optionallycomprises an insulative component that includes an opening 335 exposinga portion of the pin 105 and defining a pin weld zone 340. a conductiveelement is electrically coupled to the pin 105 in this region, forexample, by welding or swaging. The distal sleeve 330 helps to preventabrasion between a conductive element and the pin 105. Suitablematerials and/or configurations for the distal sleeve 330 include, butare not limited to, a separate pre-molded component that is assembledonto the pin, silicone or other biocompatible material. In anotheroption, the distal sleeve 330 is part of the unitary sleeve 115 and is amolded feature of the unitary sleeve 115.

FIG. 14 illustrates an embodiment of a connector assembly 100′″ having aunitary ring 110 with an extension 345 and a step down portion 350 forreceiving a connection with at least one conductive element, as shown inFIGS. 16A, 16B, 16C, and 16D. The ring 110 includes an inner ringdiameter 355 smaller than the outer distal pin diameter 360 and outerproximal pin diameter 365. The inner ring diameter 355 surrounds anintermediate pin portion 366 having an intermediate diameter and isseparated from the intermediate pin portion 366 by the sleeve 115. Thering 110, in one option, is comprised of separate ring halves 116, 118as shown in FIG. 15. The separate ring halves 116, 118 are assembled inthe mold during the molding process to surround the intermediate pinportion 366 of the pin 105. In one embodiment, the separate ring halves116, 118 are coupled together by welding them together at the interface117. In another option, the separate ring halves 116, 118 snap together.

As mentioned above, the ring 110 includes an extension 345 with a stepdown portion 350 for receiving a connection with at least one conductiveelement. a bonding surface 370 of the sleeve 115 has a reduced diameterto receive a lead body 92 (FIG. 2). As seen in FIGS. 14 and 15, thebonding surface 370 is a continuous surface having a portion that ismolded over a portion of the extension 345 step down portion 350,leaving a portion of the step down portion 350 exposed for connection toat least one conductive element. The bonding surface 370 having areduced diameter allows for the lead body 92 (FIG. 2) to have a diameterthat coincides with the exterior portion of the sleeve 115. Thisprovides for a continuous transition, and an isodiameter from the leadbody 92 (FIG. 2) to the sleeve 115. In one option, the outer proximaldiameter 365 of the pin 105 coincides with the exterior portion of thesleeve 115, the ring 110, and the lead body 92 (FIG. 2). This providesfor a continuous profile for the lead body 92 (FIG. 2) and connectorassembly 100′″.

FIG. 17 illustrates another embodiment of the ring 110. The ringincludes a first ring half 119. The first ring half 119 includes ringretention features 375, which in one option comprises apertures 380. Theapertures 380 receive a portion of the unitary sleeve 115, and assist inretaining the first ring half 119 to the sleeve 115. The second half 121of the ring 110, in one option, comprises molded material 123.

FIG. 18 illustrates an embodiment of a multi-polar connector assembly101. In one option, the multi-polar connector assembly 101 comprises atripolar connector assembly. It should be noted that the connectorassemblies discussed above are suitable for use with multi-polarassemblies such as tripolar, quadpolar, etc. For example, themulti-polar assembly 101 includes a third unitary ring. Otherembodiments include connector assemblies including four rings orgreater.

The multi-polar connector assembly 101 includes a pin 105, a first ring110″, a second ring 111, a first unitary sleeve 115″ comprised of aunitary piece of molded insulative hard polymer, and a second sleeve385. The first unitary sleeve 115″ mechanically couples the pin 105 andthe first ring 110″. The unitary sleeve 115″ also isolates the pin 105and first ring 110″ such that each is electrically isolated from theother. The second sleeve 385 mechanically couples the first unitary ring110″ and the second unitary ring 111. The second sleeve 385 alsoisolates the first ring 110″ and the second unitary ring 111 such thateach is electrically isolated from the other.

The first unitary ring 110″ includes a distal ring portion 114 extendingdistally over the distal pin portion 322. The first ring 110″ includes adistal ring portion 114 that has a distal ring diameter 390 that isreduced from the outer ring diameter 270 to provide for positioning ofthe second ring 111 over the distal ring portion 114. In one embodiment,the separator sleeve portion 395 between the first ring 10″ and thesecond ring 111 has a thickness in the range of about 0.005 inches orless.

FIG. 18 illustrates an embodiment in which the second unitary ring 111includes the features shown in FIG. 4A, FIG. 4B, FIG. 4C, and FIG. 4Dfor the ring 110. Other embodiments of the second unitary ring 30include, but are not limited to the features shown and discussed withrespect to the ring 110 in FIG. 5, FIG. 6, FIG. 7, FIG. 8, FIGS. 9A-9D,FIG. 10B, FIG. 13, FIG. 14, FIGS. 16A-16D, and FIG. 17.

The outer diameter of the second ring 111 is substantially the same asthe diameter 270 of the first ring 110″. The pin 105 has a firstdiameter 400 at the pin proximal end 120. The sleeve 115″ has an outerdiameter 405, where the first pin diameter 400 and the outer sleevediameter 405 coincide with the outer diameter of the first ring 110″ andthe second ring 111. The lead body further coincides with the outerdiameter of the connector assembly 101. This forms an isodiametricconnector assembly having a continuous uninterrupted profile for theentire connector assembly 101. This simplifies specifications forimplantable devices such as pulse generator designs which receive theconnector assembly 101.

In one embodiment, the outer diameter of a tripolar connector assembly101 is in the range of about 0.07-0.12, and in one option 0.07-0.08inches. In another embodiment, the outer diameter of the tripolarconnector assembly 101 is in the range of about 0.08-0.09 inches. Thetripolar connector assembly 101 is suitable for use in a pacemaker,cardioverter, anti-tachycardia device, and defibrillator.

In one embodiment, a tripolar connector assembly 101 is manufactured byplacing the pin 105, the first ring 110″ and the second ring 111 in amold, and the first unitary sleeve 115 and second sleeve 385 are moldedapproximately at the same time around the pin 105, the first ring 110″,and the second ring 111. In one embodiment, the tripolar connectorassembly 101 is manufactured with a first ring 110″ having passages inthe distal portion of the first ring 110″. During molding, in oneoption, the insulative hard polymer fills the passages of the firstunitary ring 110″ such that first sleeve 115″ and second sleeve 385 arecombined as a single unitary sleeve.

a method is further provided, which incorporates the embodimentsdiscussed above, or combinations thereof. The method includes forming apin, forming at least one ring, molding a sleeve between the pin and thering, including mechanically coupling the pin with the ring. Severaloptions for the method are as follows. For instance, the method furthercomprises coupling a lead with the pin, the at least one ring, and thesleeve to form an assembly having an isodiametric outer diameter. In oneoption, a conductor is coupled with the ring and/or the pin, which canoccur before or after the molding process. In addition, a suitablematerial such as epoxy, or molding material is backfilled over theconductor in another option. In yet another option, the method furtherincludes forming a second ring, and molding the sleeve between the ring,the pin, and the second ring. In yet another option, the method furtherincludes swaging a conductor within a passage of the at least one ring,and/or welding a conductor within a passage of the at least one ring. afurther option for the method includes forming an extension on the ring,and/or forming a partial boss and a partial chamfer on the extension.

Various embodiments have been presented for coupling electricallyconducting components together, for example, for coupling at least oneconductive element to the pin or ring. The welding techniques include,but are not limited to laser welding, resistance welding or buttwelding. Other embodiments for coupling a conductor element may includebut are not limited to using a conductive adhesive to couple theconductive element to the pin or ring.

In a connector, the size of the components and the area of contactbetween the components may affect the mechanical strength of the weld orbond and thus may affect the mechanical strength of the connector. Onebenefit of forming the sleeve from the molded insulative hard polymer isthat it allows the connector assembly to be assembled from just the pin,the ring, and the sleeve. Thus, eliminating weld connections betweenadditional components, and eliminating adhesive bonds betweencomponents.

Forming the sleeve from the insulative hard polymer also allows theconnector assembly to be molded to smaller dimensions while providing anincreased pull strength to the connector assembly. Because of therigidity of the material and because no weld or adhesive bond isrequired to couple components of the connector assembly, the surfacearea of the components does not affect the strength of the connectionbetween components. As a result, the connector may include shorter ringlengths while also providing an improved pull strength. In oneembodiment, the pull strength is greater than about 10 lbs. In oneembodiment, the pull strength is in the range of about 10-25 lbs. In oneembodiment, the pull strength is about 25 lbs.

Forming the sleeve from the insulative hard polymer also providesgreater dimensional consistency. As a result, the connector assembly hasimproved tolerances. Thus, the connector assembly provides the necessaryfit with the structure of the pulse generator with an improved assemblyprocess. The dimensional consistency and mechanical strength ismaintained in the radial direction by the rigidity of the material.

Advantageously, the connector assembly has fewer components, fewer stepsin the assembly process, improved size, improved insulative propertiesand improved mechanical strength than previous connector assemblies.Since the connector is made with a smaller volume, the device with whichthe connector operates can be made smaller, for example the header.Furthermore, the connector design allows for greater dimensionalconsistency. Possible applications of the connector assembly include,but are not limited to, cardiac stimulators such as a pacemaker, ananti-tachycardia device, a cardioverter, or a defibrillator. Althoughpulse generators for cardiac stimulators have been discussed,application of the connector assembly is not to be limited to use with acardiac stimulator. For instance, the connector assembly is suitable foruse with neural transmitter lead assemblies and other applications aswell. In addition, the connector assembly is suitable for use with othersources of electrical energy, sensing instruments or combinations ofdevices. It should be further noted that the connector assembly issuitable for use in low and high voltage applications in a single port.

It is to be understood that the above description is intended to beillustrative, and not restrictive. Many other embodiments will beapparent to those of skill in the art upon reading and understanding theabove description. It should be noted that embodiments discussed indifferent portions of the description or referred to in differentdrawings can be combined to form additional embodiments of the presentinvention. The scope of the invention should, therefore, be determinedwith reference to the appended claims, along with the full scope ofequivalents to which such claims are entitled.

What is claimed is:
 1. A connector assembly comprising: a pin extendingfrom a pin distal end to a pin proximal end, and having a pinintermediate portion therebetween; at least one ring extending from aring distal end to a ring proximal end and having a ring intermediateportion therebetween; a molded insulative polymer between the pin andthe ring, the polymer mechanically coupling the pin and the ring, andthe insulative polymer insulating the pin from the ring; wherein the pinincludes at least one chamfer formed thereon.
 2. The connector assemblyas recited in claim 1, wherein the pin has a first outer diameter andthe ring has a second outer diameter, and the first diameter issubstantially the same as the second diameter.
 3. The connector assemblyas recited in claim 1, further comprising a second ring, and theinsulative polymer is between the pin, the first ring and the secondring, the second ring mechanically coupled to the pin by the polymer. 4.The connector assembly as recited in claim 1, wherein the ring furtherincludes at least one passage, and the molded polymer is molded withinthe at least one passage.
 5. The connector assembly as recited in claim1, wherein the molded insulative polymer is molded within the chamfer.6. The connector assembly as recited in claim 1, wherein the ringincludes a full boss and a full chamfer.
 7. The connector assembly asrecited in claim 1, wherein an interior surface of the ring includesgrooves formed thereon.
 8. The connector assembly as recited in claim 7,wherein the grooves are oblique to a longitudinal axis of the ring. 9.The connector assembly as recited in claim 1, wherein the pin furtherincludes a boss formed thereon.
 10. The connector assembly as recited inclaim 9, wherein the pin boss further includes grooves formed thereon.11. The connector assembly as recited in claim 10, wherein the pinfurther includes grooves formed on a distal portion of the pin.
 12. Theconnector assembly as recited in claim 1, wherein the connector assemblyfurther includes a groove on an outer diameter of the connectorassembly, the groove configured to receive a portion of a pulsegenerator.
 13. A connector assembly comprising: a pin extending from apin distal end to a pin proximal end, and having a pin intermediateportion therebetween; at least one ring extending from a ring distal endto a ring proximal end and having a ring intermediate portiontherebetween; a molded insulative polymer between the pin and the ring,the polymer mechanically coupling the pin and the ring, and theinsulative polymer insulating the pin from the ring; the ring includes afull boss and a full chamfer; wherein the ring includes an extensionthereon, the extension having a partial boss and a partial chamferthereon.
 14. An assembly comprising: a connector assembly including: apin extending from a pin distal end to a pin proximal end, and having apin intermediate portion therebetween; at least one ring extending froma ring distal end to a ring proximal end and having a ring intermediateportion therebetween; a molded insulative polymer between the pin andthe ring, the polymer mechanically coupling the pin and the ring, andthe insulative polymer insulating the pin from the ring; and a leadhaving a lead body, the lead coupled with the connector assembly whereinthe connector assembly further includes a groove on an outer diameter ofthe connector assembly, the groove configured to receive a portion of apulse generator.
 15. The connector assembly as recited in claim 14,wherein the pin has at least one chamfer formed thereon.
 16. Theconnector assembly as recited in claim 14, wherein the connectorassembly has a first outer diameter, the lead having a second outerdiameter, and the first outer diameter and the second outer diameter aresubstantially the same.
 17. The connector assembly as recited in claim14, wherein the connector assembly further includes a second groove onthe outer diameter.
 18. The connector assembly as recited in claim 14,further comprising a second ring, and a third ring, and the insulativepolymer is between the pin, the first ring, the second ring, and thethird ring, the second ring and the third ring mechanically coupled tothe pin by the polymer.
 19. The connector assembly as recited in claim14, wherein the pin further includes a pin boss formed thereon, and thepin boss further includes grooves formed thereon.
 20. A methodcomprising: forming a pin; forming at least one ring; and molding asleeve between the pin and the ring, including mechanically coupling thepin with the ring; coupling a conductor with the ring and/or the pinprior to molding the sleeve.
 21. The method as recited in claim 20,further comprising coupling a lead with the pin, the at least one ring,and the sleeve to form an assembly having an isodiametric outerdiameter.
 22. The method as recited in claim 20, further comprisingforming a second ring, and molding the sleeve between the ring, the pin,and the second ring.
 23. The method as recited in claim 20, furthercomprising swaging a conductor within a passage of the at least onering.
 24. The method as recited in claim 20, further comprising weldinga conductor within a passage of the at least one ring.
 25. The method asrecited in claim 20, further comprising forming an extension on thering.
 26. The method as recited in claim 25, further comprising forminga partial boss and a partial chamfer on the extension.
 27. The method asrecited in claim 26, further comprising forming a full boss and a fullchamfer on the at least one ring.
 28. The method as recited in claim 20,further comprising forming ridges in the pin, and molding polymermaterial within the ridges.
 29. The method as recited in claim 20,further comprising forming ridges in the pin at an angle oblique to alongitudinal axis of the pin, and molding polymer material within theridges.
 30. The method as recited in claim 20, wherein mechanicallycoupling the pin with the ring includes forming an isodiametricconnector assembly.
 31. A method comprising: forming a pin; forming achamfer on the pin; mechanically coupling the pin with the ring; andinsulating the pin from the ring including molding a sleeve between thepin and the ring.
 32. The method as recited in claim 31, furthercomprising coupling a conductor with the ring and/or the pin.
 33. Themethod as recited in claim 31, wherein coupling the conductor occursprior to molding the sleeve.
 34. The method as recited in claim 31,further comprising forming ridges in the pin at an angle oblique to alongitudinal axis of the pin, and molding polymer material within theridges.